510(k) K881465

Device
CRYOBIOLOGICAL FREEZER
Applicant
CRYODYNE TECHNOLOGIES, INC.
510(k) number
K881465
Product code
KSP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-21
Date received
1988-04-06
Regulation
864.9225
Classification name
Apparatus, Cell-freezing And Reagents
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEAN W SCHILLING
Address
400 Hoover Rd. Soquel CA US 95073 95073

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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